Eosinophilic Esophagitis (EoE)ESCAPENCT07102329
BURDEN OF ESOPHAGEAL CANCER IN EOSINOPHILIC ESOPHAGITIS (ESCAPE STUDY)
An observational study of Eosinophilic Esophagitis (EoE), run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory disorder of the esophagus that can lead to symptoms such as dysphagia and food impaction. In recent years, a potential association between EoE and esophageal cancer (EC) has been proposed, though evidence remains inconsistent and may be… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Eosinophilic Esophagitis (EoE)
- How many people
- 100,000 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jul 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: - EoE diagnosed patients according to ICD-10 code K20, compared to control population
Who may be able to join
- EoE diagnosed patients according to ICD-10 code K20
Who cannot join
- Patients diagnosed with other EGIDs (- K52.81: Eosinophilic Gastritis or Gastroenteritis
- K52.82: Eosinophilic Colitis
- K558.4: Eosinophilic gastroenteritis and colitis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE REAL-LIFE BURDEN OF ESOPHAGEAL CANCER IN EOSINOPHILIC ESOPHAGITIS: A COMPARATIVE PROPENSITY-MATCHED ANALYSIS FROM A GLOBAL MULTICENTER DATABASE (THE ESCAPE STUDY)
Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory disorder of the esophagus that can lead to symptoms such as dysphagia and food impaction. In recent years, a potential association between EoE and esophageal cancer (EC) has been proposed, though evidence remains inconsistent and may be influenced by overlapping conditions like gastroesophageal reflux disease (GERD) and Barrett's esophagus (BE).
The purpose of this study was to determine whether patients with EoE are at increased risk of developing esophageal cancer, and to clarify whether any observed risk is intrinsic to EoE or instead related to coexisting GERD or BE.
The main research question was: Is eosinophilic esophagitis independently associated with an increased risk of esophageal cancer, or is this risk mediated by overlapping conditions such as GERD or Barrett's esophagus? To address this, we conducted a retrospective, multicenter cohort study using real-world data from TriNetX, a global federated health research network aggregating electronic medical records from approximately 100 million patients.
Read the detailed description
Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory disease of the esophagus, often presenting with symptoms such as dysphagia and food impaction. Recent literature has raised concerns about a potential association between EoE and the development of esophageal cancer (EC), though findings are inconsistent and possibly confounded by coexisting gastroesophageal reflux disease (GERD) or Barrett's esophagus (BE).
The objective of this study was to assess whether EoE independently increases the risk of esophageal cancer, or whether any observed risk is primarily driven by overlapping conditions such as GERD or BE.
This was a retrospective, multicenter cohort study utilizing TriNetX, a global federated health research network that provides access to real-world data from electronic medical records (EMRs) of over 100 million patients across more than 100 large healthcare organizations (HCOs), predominantly located in the United States. The network supports cohort design, real-time analytics, and privacy-preserving analytics within a federated data environment.
Patients were selected based on the ICD-10 diagnosis code for eosinophilic esophagitis (K20.0) recorded between January 1, 2000, and March 31, 2025. To isolate the specific contribution of EoE to cancer risk, two distinct EoE cohorts were defined:
Cohort A: All patients with a diagnosis of EoE, excluding only other eosinophilic gastrointestinal disorders (EGIDs), thereby including individuals with coexisting GERD or BE Cohort B: A more stringently defined "pure EoE" group, excluding patients with any diagnosis of GERD, BE, or other EGIDs, in order to assess the cancer risk attributable to EoE in isolation.
Each EoE cohort was compared to a control cohort comprising patients who had outpatient encounters for non-specific or undefined reasons (ICD-10 Z00), and who had no recorded diagnosis of EoE and any instance of EC or BE before the index event.
To reduce bias and account for confounding factors, a 1:1 propensity score matching was performed using a nearest-neighbor greedy algorithm, with several matching variables.
Time-to-event analysis was designed using Kaplan-Meier survival curves, with censoring applied at the last clinical encounter. Comparative analysis of cancer incidence between groups was planned through log-rank testing, and both hazard ratios (HRs) and risk differences (RDs) were to be calculated.
This study design aims to provide a clearer understanding of whether EoE itself constitutes an independent risk factor for esophageal cancer, after accounting for potential confounding conditions.
- Conditions
- Eosinophilic Esophagitis (EoE)
- Keywords
- Eosinophilic Esophagitis, Esophageal Cancer, Gastroesophageal Reflux Disease, Barrett Esophagus, Risk
- Medical subject headings
- Eosinophilic Esophagitis, Esophageal Neoplasms, Gastroesophageal Reflux, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A) primary cohort of EoE patients | The primary cohort of the main analysis was built to include all eosinophilic esophagitis (EoE) patients, therefore implementing the ICD-10 code specific for the disease (K20.0). In order not to include other eosinophilic gastrointestinal disorders (EGIDs) primary cohort was built excluding the following ICD-10(ICD-9) codes: * K52.81: Eosinophilic Gastritis or Gastroenteritis * K52.82: Eosinophilic Colitis * K558.4: Eosinophilic gastroenteritis and colitis Following diagnosis were excluded if happened on or before the index event: * ICD-10-K22.7 Barrett Esophagus * ICD-10-K22.71 Barrett Esophagus with dysplasia * ICD-10-K22.711 Barrett Esophagus with high-grade dysplasia * ICD-10-K22.719 Barrett Esophagus with dysplasia, unspecified * ICD-10-K22.710 Barrett Esophagus with low-grade dysplasia * ICD-10-K22.1 Ulcer of the esophagus * ICD-10-K22.10 Ulcer of the esophagus without bleeding * ICD-10-K22.11 Ulcer of the esophagus with bleeding * ICD-10-C15 Esophageal cancer | |
| Cohort B: Pure EoE without BE/GERD | The secondary cohort (Cohort B) of the main analysis was built to include all eosinophilic esophagitis (EoE) patients, therefore implementing the ICD-10 code specific for the disease (K20.0). In order not to include other eosinophilic gastrointestinal disorders (EGIDs) leading to confounding clinical profiles, this primary cohort was built excluding the following ICD-10(ICD-9) codes: * K52.81: Eosinophilic Gastritis or Gastroenteritis * K52.82: Eosinophilic Colitis * K558.4: Eosinophilic gastroenteritis and colitis To eliminate the confounding effect of BE and objective GERD was built with the exclusion from cohort A of the following diagnosis: * ICD-10-K22.7 Barrett Esophagus * ICD-10-K22.71 Barrett Esophagus with dysplasia * ICD-10-K22.711 Barrett Esophagus with high-grade dysplasia * ICD-10-K22.719 Barrett Esophagus with dysplasia, unspecified * ICD-10-K22.710 Barrett Esophagus with low-grade dysplasia * ICD-10-K22.1 Ulcer of the esophagus * ICD-10-K22.11 Ulcer of the esophagus with bleeding | |
| Control group | The control group cohort was built in order to minimize the risk of selection bias, using the general code for "encounter for general examination without complaint, suspected or reported diagnosis" ICD-10 Z00 with the exclusion of the following codes related to EoE diagnosis (ICD10-K20.0). In order to minimize the overestimation of time-to-event risk of primary outcome, the following diagnosis were excluded if happened on or before the index event: * ICD-10-K22.7 Barrett Esophagus * ICD-10-K22.71 Barrett Esophagus with dysplasia * ICD-10-K22.711 Barrett Esophagus with high-grade dysplasia * ICD-10-K22.719 Barrett Esophagus with dysplasia, unspecified * ICD-10-K22.710 Barrett Esophagus with low-grade dysplasia * ICD-10-K22.1 Ulcer of the esophagus * ICD-10-K22.10 Ulcer of the esophagus without bleeding * ICD-10-K22.11 Ulcer of the esophagus with bleeding * ICD-10-C15 Esophageal cancer To restrict the number of patients in the control group only patients with an "ambulatory" encounter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard Ratio (HR) of esophageal cancer (EC) in EoE cohort A versus controls
Hazard ratios (HRs) and 95% confidence intervals (CIs) for EC development in cohort A versus controls, derived from Cox proportional hazards models, where cohort assignment served as the primary covariate. The proportional hazards assumption was evaluated using the generalized Schoenfeld residuals method.
Measured: from January 2000 to July 2025
Secondary outcomes (3)
Hazard Ratio (HR) of esophageal cancer (EC) in EoE cohort B versus controls
Hazard ratios (HRs) and 95% confidence intervals (CIs) for EC development in cohort A versus controls, derived from Cox proportional hazards models, where cohort assignment served as the primary covariate. The proportional hazards assumption was evaluated using the generalized Schoenfeld residuals method.
Secondary analysis in order to extract the real estimate of having EC in pure EoE versus controls.
Measured: From January 2000 to July 2025
Hazard Ratio (HR) of adenocarcinoma (EAC) or squamous cell carcijoma (SCC in EoE cohort A versus controls
Hazard ratios (HRs) and 95% confidence intervals (CIs) for EAC vs SCC development in cohort A versus controls, derived from Cox proportional hazards models, where cohort assignment served as the primary covariate. The proportional hazards assumption was evaluated using the generalized Schoenfeld residuals method.
Measured: from January 2000 to July 2025
Hazard Ratio (HR) of adenocarcinoma (EAC) or squamous cell carcijoma (SCC in pure EoE cohort B versus controls
Hazard ratios (HRs) and 95% confidence intervals (CIs) for EAC vs SCC development in cohort B versus controls, derived from Cox proportional hazards models, where cohort assignment served as the primary covariate. The proportional hazards assumption was evaluated using the generalized Schoenfeld residuals method.
Measured: from January 2000 to July 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start23 Jul 2025
- Primary completion30 Jul 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic Esophagitis (EoE)Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- TriNetX, LLC, Università Vita-Salute San Raffaele
- Responsible party
- Principal investigator, Alberto Barchi, IRCCS San Raffaele
- Investigators
- Alberto Barchi, MD, Principal investigator, IRCCS San Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102329
- Sponsor's protocol ID
- ESCAPE-1
- Acronym
- ESCAPE
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD used
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE REAL-LIFE BURDEN OF ESOPHAGEAL CANCER IN EOSINOPHILIC ESOPHAGITIS: A COMPARATIVE PROPENSITY-MATCHED ANALYSIS FROM A GLOBAL MULTICENTER DATABASE (THE ESCAPE STUDY)
- ClinicalTrials.gov ID
- NCT07102329
- Acronym / sponsor ID
- ESCAPE / ESCAPE-1
- Conditions
- Eosinophilic Esophagitis (EoE)
- Keywords
- Eosinophilic Esophagitis, Esophageal Cancer, Gastroesophageal Reflux Disease, Barrett Esophagus, Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- TriNetX, LLC, Università Vita-Salute San Raffaele
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory disorder of the esophagus that can lead to symptoms such as dysphagia and food impaction. In recent years, a potential association between EoE and esophageal cancer (EC) has been proposed, though evidence remains inconsistent and may be influenced by overlapping conditions like gastroesophageal reflux disease (GERD) and Barrett's esophagus (BE).
The purpose of this study was to determine whether patients with EoE are at increased risk of developing esophageal cancer, and to clarify whether any observed risk is intrinsic to EoE or instead related to coexisting GERD or BE.
The main research question was: Is eosinophilic esophagitis independently associated with an increased risk of esophageal cancer, or is this risk mediated by overlapping conditions such as GERD or Barrett's esophagus? To address this, we conducted a retrospective, multicenter cohort study using real-world data from TriNetX, a global federated health research network aggregating electronic medical records from approximately 100 million patients.
Detailed description
Eosinophilic esophagitis (EoE) is a chronic, immune-mediated inflammatory disease of the esophagus, often presenting with symptoms such as dysphagia and food impaction. Recent literature has raised concerns about a potential association between EoE and the development of esophageal cancer (EC), though findings are inconsistent and possibly confounded by coexisting gastroesophageal reflux disease (GERD) or Barrett's esophagus (BE).
The objective of this study was to assess whether EoE independently increases the risk of esophageal cancer, or whether any observed risk is primarily driven by overlapping conditions such as GERD or BE.
This was a retrospective, multicenter cohort study utilizing TriNetX, a global federated health research network that provides access to real-world data from electronic medical records (EMRs) of over 100 million patients across more than 100 large healthcare organizations (HCOs), predominantly located in the United States. The network supports cohort design, real-time analytics, and privacy-preserving analytics within a federated data environment.
Patients were selected based on the ICD-10 diagnosis code for eosinophilic esophagitis (K20.0) recorded between January 1, 2000, and March 31, 2025. To isolate the specific contribution of EoE to cancer risk, two distinct EoE cohorts were defined:
Cohort A: All patients with a diagnosis of EoE, excluding only other eosinophilic gastrointestinal disorders (EGIDs), thereby including individuals with coexisting GERD or BE Cohort B: A more stringently defined "pure EoE" group, excluding patients with any diagnosis of GERD, BE, or other EGIDs, in order to assess the cancer risk attributable to EoE in isolation.
Each EoE cohort was compared to a control cohort comprising patients who had outpatient encounters for non-specific or undefined reasons (ICD-10 Z00), and who had no recorded diagnosis of EoE and any instance of EC or BE before the index event.
To reduce bias and account for confounding factors, a 1:1 propensity score matching was performed using a nearest-neighbor greedy algorithm, with several matching variables.
Time-to-event analysis was designed using Kaplan-Meier survival curves, with censoring applied at the last clinical encounter. Comparative analysis of cancer incidence between groups was planned through log-rank testing, and both hazard ratios (HRs) and risk differences (RDs) were to be calculated.
This study design aims to provide a clearer understanding of whether EoE itself constitutes an independent risk factor for esophageal cancer, after accounting for potential confounding conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A) primary cohort of EoE patients | – | –The primary cohort of the main analysis was built to include all eosinophilic esophagitis (EoE) patients, therefore implementing the ICD-10 code specific for the disease (K20.0). In order not to include other eosinophilic gastrointestinal disorders (EGIDs) primary cohort was built excluding the following ICD-10(ICD-9) codes: * K52.81: Eosinophilic Gastritis or Gastroenteritis * K52.82: Eosinophilic Colitis * K558.4: Eosinophilic gastroenteritis and colitis Following diagnosis were excluded if happened on or before the index event: * ICD-10-K22.7 Barrett Esophagus * ICD-10-K22.71 Barrett Esophagus with dysplasia * ICD-10-K22.711 Barrett Esophagus with high-grade dysplasia * ICD-10-K22.719 Barrett Esophagus with dysplasia, unspecified * ICD-10-K22.710 Barrett Esophagus with low-grade dysplasia * ICD-10-K22.1 Ulcer of the esophagus * ICD-10-K22.10 Ulcer of the esophagus without bleeding * ICD-10-K22.11 Ulcer of the esophagus with bleeding * ICD-10-C15 Esophageal cancer |
| Cohort B: Pure EoE without BE/GERD | – | –The secondary cohort (Cohort B) of the main analysis was built to include all eosinophilic esophagitis (EoE) patients, therefore implementing the ICD-10 code specific for the disease (K20.0). In order not to include other eosinophilic gastrointestinal disorders (EGIDs) leading to confounding clinical profiles, this primary cohort was built excluding the following ICD-10(ICD-9) codes: * K52.81: Eosinophilic Gastritis or Gastroenteritis * K52.82: Eosinophilic Colitis * K558.4: Eosinophilic gastroenteritis and colitis To eliminate the confounding effect of BE and objective GERD was built with the exclusion from cohort A of the following diagnosis: * ICD-10-K22.7 Barrett Esophagus * ICD-10-K22.71 Barrett Esophagus with dysplasia * ICD-10-K22.711 Barrett Esophagus with high-grade dysplasia * ICD-10-K22.719 Barrett Esophagus with dysplasia, unspecified * ICD-10-K22.710 Barrett Esophagus with low-grade dysplasia * ICD-10-K22.1 Ulcer of the esophagus * ICD-10-K22.11 Ulcer of the esophagus with bleeding |
| Control group | – | –The control group cohort was built in order to minimize the risk of selection bias, using the general code for "encounter for general examination without complaint, suspected or reported diagnosis" ICD-10 Z00 with the exclusion of the following codes related to EoE diagnosis (ICD10-K20.0). In order to minimize the overestimation of time-to-event risk of primary outcome, the following diagnosis were excluded if happened on or before the index event: * ICD-10-K22.7 Barrett Esophagus * ICD-10-K22.71 Barrett Esophagus with dysplasia * ICD-10-K22.711 Barrett Esophagus with high-grade dysplasia * ICD-10-K22.719 Barrett Esophagus with dysplasia, unspecified * ICD-10-K22.710 Barrett Esophagus with low-grade dysplasia * ICD-10-K22.1 Ulcer of the esophagus * ICD-10-K22.10 Ulcer of the esophagus without bleeding * ICD-10-K22.11 Ulcer of the esophagus with bleeding * ICD-10-C15 Esophageal cancer To restrict the number of patients in the control group only patients with an "ambulatory" encounter. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - EoE diagnosed patients according to ICD-10 code K20, compared to control population
Key inclusion criteria (1 listed)
- EoE diagnosed patients according to ICD-10 code K20
Key exclusion criteria (3 listed)
- Patients diagnosed with other EGIDs (- K52.81: Eosinophilic Gastritis or Gastroenteritis
- K52.82: Eosinophilic Colitis
- K558.4: Eosinophilic gastroenteritis and colitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hazard Ratio (HR) of esophageal cancer (EC) in EoE cohort A versus controls
Time frame: from January 2000 to July 2025
Hazard ratios (HRs) and 95% confidence intervals (CIs) for EC development in cohort A versus controls, derived from Cox proportional hazards models, where cohort assignment served as the primary covariate. The proportional hazards assumption was evaluated using the generalized Schoenfeld residuals method.
3 secondary outcomes
Hazard Ratio (HR) of esophageal cancer (EC) in EoE cohort B versus controls
Time frame: From January 2000 to July 2025
Hazard Ratio (HR) of adenocarcinoma (EAC) or squamous cell carcijoma (SCC in EoE cohort A versus controls
Time frame: from January 2000 to July 2025
Hazard Ratio (HR) of adenocarcinoma (EAC) or squamous cell carcijoma (SCC in pure EoE cohort B versus controls
Time frame: from January 2000 to July 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No. No IPD used
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Barchi, MD principal investigator
IRCCS San Raffaele Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis (EoE), run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hazard Ratio (HR) of esophageal cancer (EC) in EoE cohort A versus controls (time frame: from January 2000 to July 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.